Depressive Disorder
Conditions
Keywords
depression, double-blind, placebo-controlled, bupropion hydrochloride, SSRI, comparative study, non-responder
Brief summary
This study is designed to evaluate the efficacy and safety in depressive patients who did not respond sufficiently to selective serotonin re-uptake inhibitors (SSRI).
Interventions
DRUG323U66 (Bupropion Hydrochloride Sustained Release)
Subjects with Major Depressive Disorder who were randomized to take 100mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100mg dose of Bupropion morning and evening. Weeks 3 thru 12 received 150mg dose morning and evening. Week 1=dose level 1, 100 mg. Week 2=dose level 2, 200 mg. Weeks 3 - 12=dose level 3, 300 mg.
DRUGPlacebo
Subjects with Major Depressive Disorder who were randomised to placebo to match Bupropion SR during the treatment period.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* \[At the start of the pretreatment phase\] * Target disease: Patients diagnosed as having the following primary disease on the basis of DSM-IV-TR criteria. * Major Depressive Disorder, Single Episode (296.2x) (excluding with psychotic features) * Major Depressive Disorder, Recurrent (296.3x) (excluding with psychotic features) * HAM-D (17 items) total score is \>=16. * Patients who have been treated with marketed paroxetine (Paxil®) at 20mg/day to 40mg/day for 4 weeks and more at the start of the pretreatment phase. * Age: \>=18 years old (at the time of informed consent) , \<65 years old (at the start of treatment phase ) * Gender: Male or female. * Inpatients or outpatients: Either * Informed consent: The subject himself/herself must give written informed consent. However, if the subject is under 20 at the time of giving consent, both the subject himself/herself and his/her legally acceptable representative must give written informed consent. \[At the end of the pretreatment phase\] 1. HAM-D (17 items) total score is ≥14. 2. Percentage of change from the start of the pretreatment phase in the HAM-D (17 items) total score is \<50% \[At the start of the treatment phase\] 1. HAM-D (17 items) total score is ≥14. 2. Percentage of change from the start of the pretreatment phase in the HAM-D (17 items) total score is \<50%
Exclusion criteria
\[At the start of the pre-treatment phase\] * Patients with a complication of glaucoma * Patients concomitantly using a drug increasing the risk of bleeding and patients with bleeding tendency or predisposition to bleeding * Patients with predisposition to seizure (who currently have or have a past history of seizure, febrile convulsive seizure in infancy, cerebral tumour, cerebrovascular disorder or head injury, who have a family history of idiopathic seizure, patients with diabetes who have been treated with oral hypoglycaemics or insulin, or who use drugs lowering the threshold of seizure). * Patients who currently have or have a past history of the following disorders: * Anorexia nervosa (DSM-IV-TR 307.1) * Bulimia nervosa (DSM-IV-TR 307.51) * Patients with a history of manic episode * Patients with a past or current DSM- IV-TR diagnosis of schizophrenia or other psychotic disorder * Patients with a current DSM-IV-TR Axis II diagnosis (e.g., antisocial or borderline personality disorder) * Patients starting psychotherapy (except for supportive psychotherapy not aimed at therapeutic efficacy and unlikely to affect efficacy evaluation) and formal cognitive behaviour therapy within 5 weeks prior to the start of the pre-treatment phase * Patients with a diagnosis of substance abuse (alcohol or drug) by the DSM-IV-TR criteria or with a diagnosis of substance dependence within 1 year prior to the start of the pre-treatment phase * Patients who have received electroconvulsive therapy within 17 weeks prior to the start of the pre-treatment phase * Patients who have taken MAO inhibitors (selegiline hydrochloride) within 2 weeks prior to the start of the pre-treatment phase * Patients who have taken another investigational drug within 12 weeks prior to the start of the pre-treatment phase * Female patients who are pregnant, possibly pregnant or are nursing, and those who want to become pregnant before 30 days after the last dose of the investigational product * Patients who have attempted suicide within 17 weeks prior to the start of the pre-treatment phase, or patients for whom the score of suicide-related item No. 3 of HAM-D is \>=3, or patients in whom the risk of suicide is judged to be high by the investigator (sub-investigator) * Patients in whom the risk of homicide is judged to be high by the investigator (sub-investigator) * Patients with a history of hypersensitivity to 323U66 and/or paroxetine * Patients with serious cerebral disease * Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) feels may predispose the subject to ischemia or arrhythmia * Patients with serious physical symptoms (i.e. cardiac/hepatic/renal disorder, hematopoietic disorder) The index of seriousness is Grade 3 of Criteria for classification of seriousness of adverse drug reactions to pharmaceutical products, etc. (PAB/PSD No.80 in 1992). * Patients with a history or complication of cancer or malignant tumour. * Patients whose major depressive disorder is due to direct physiological effects of a general medical condition (for example, hypothyroidism, Parkinson's disease, chronic pain) * Patients with systolic blood pressure of \>=160 mmHg or diastolic blood pressure of \>=100 mmHg * Patients who are inappropriate for participating in the study in the judgement of the investigator (sub-investigator) \[At the start of the treatment phase\] 1. Patients whose compliance of paroxetine during the pretreatment phase is less than 70%. 2. Patients who have ECG or clinical evidence of any cardiac condition that the investigator (sub-investigator) feels may predispose the subject to ischemia or arrhythmia 3. Patients with systolic blood pressure of \>=160 mmHg or diastolic blood pressure of \>=100 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score | Baseline and Week 12 | The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12 | Baseline to Week 8 and Week 12 | The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). |
| Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12. | Baseline to Week 8 and Week 12 | The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). |
| Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Baseline to Week 8 and Week 12 | The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Responders are defined as subjects with 50% or greater reduction from baseline in HAM-D total score. |
| Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Baseline to Week 8 and Week 12 | The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Remitters are defined as subjects with HAM-D total score ≤ 7. |
| Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Baseline to Week 8 and Week 12 | The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill). |
| Hamilton Depression Scale (HAM-D 17 Items) Total Score | Week 8 and Week 12 | The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). |
| Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Baseline to Weeks 1, 2, 3, 4, 8, and 12 | The 7-point Clinical Global Impressions-Severity of Illness Scale (CGI-S) measures the severity of psychiatric symptoms. The following scores can be given: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients. |
| Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12 | Baseline to Week 8 and Week 12 | The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I. |
| Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12 | Week 12 | Kaplan-Meier estimates were calculated using event or censoring and time to event or censoring. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12). |
| Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Baseline to Week 12 | Assessment of intensity was based on investigators/subinvestigator's clinical judgement per protocol instructions: Mild event, easily tolerated, with minimal discomfort and not interfering with Activities of Daily Living (ADLs); moderate event, with discomfort that interferes with ADLs; severe event, prevents ADLs. |
| Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Baseline to Week 8 and Week 12 | The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill). |
Countries
Japan
Participant flow
Pre-assignment details
Pre-treatment period: Paroxetine 40 mg/day was administered for four weeks in subjects treated with marketed paroxetine between doses of 20 and 40 mg/day for four weeks or more prior to tapering pretreatment period. Tapering pretreatment period: Paroxetine was tapered down weekly by 10 mg/day in subjects who were progressed to treatment period.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period. | 157 |
| Bupropion SR Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg. | 165 |
| Total | 322 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Dose Level 2 - Week 2 | Adverse Event | 1 | 5 |
| Dose Level 2 - Week 2 | Withdrawal by Subject | 1 | 0 |
| Dose Level 3 - Weeks 3-12 | Adverse Event | 30 | 34 |
| Dose Level 3 - Weeks 3-12 | Lack of Efficacy | 3 | 6 |
| Dose Level 3 - Weeks 3-12 | Lost to Follow-up | 3 | 2 |
| Dose Level 3 - Weeks 3-12 | Non - Compliance | 1 | 0 |
| Dose Level 3 - Weeks 3-12 | Other | 0 | 2 |
| Dose Level 3 - Weeks 3-12 | Protocol Violation | 1 | 0 |
| Dose Level 3 - Weeks 3-12 | Withdrawal by Subject | 7 | 18 |
Baseline characteristics
| Characteristic | Placebo | Bupropion SR | Total |
|---|---|---|---|
| Age, Continuous | 36.0 Years STANDARD_DEVIATION 8.91 | 36.8 Years STANDARD_DEVIATION 9.28 | 36.4 Years STANDARD_DEVIATION 9.1 |
| Region of Enrollment Japan | 157 participants | 165 participants | 322 participants 0 |
| Sex: Female, Male Female | 69 Participants | 77 Participants | 146 Participants |
| Sex: Female, Male Male | 88 Participants | 88 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 124 / 159 | 125 / 166 |
| serious Total, serious adverse events | 0 / — | 5 / — |
Outcome results
Primary
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
Time frame: Baseline and Week 12
Population: Full Analysis Set was all subjects who entered the treatment phase with the exception of those who did not take any investigational products during the treatment phase and those who did not meet the major eligibility criteria of Major Depressive Disorder or those with no valid post baseline assessment. Week 12/LOCF placebo = 155, Bupropion SR = 160
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score | Baseline | 19.8 Score in scale | Standard Deviation 4.34 |
| Placebo | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score | Week 12 or Last Observation Carried Forward | 14.7 Score in scale | Standard Deviation 8.89 |
| Placebo | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score | Change from Baseline | -5.1 Score in scale | Standard Deviation 8.02 |
| Bupropion SR | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score | Baseline | 19.4 Score in scale | Standard Deviation 4.39 |
| Bupropion SR | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score | Week 12 or Last Observation Carried Forward | 14.6 Score in scale | Standard Deviation 9.09 |
| Bupropion SR | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score | Change from Baseline | -4.9 Score in scale | Standard Deviation 8.34 |
Comparison: Null Hypothesis: The population mean change from baseline on HAM-D total score at Week 12 of the placebo group is equal to the population mean change from baseline on HAMD total score at Week 12 of the Bupropion hydrochloride sustained release group.p-value: 0.80595% CI: [-1.6, 2]ANOVA
Secondary
Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12
The 7-point Clinical Global Impressions-Severity of Illness Scale (CGI-S) measures the severity of psychiatric symptoms. The following scores can be given: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill patients.
Time frame: Baseline to Weeks 1, 2, 3, 4, 8, and 12
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 4 Mean LOCF, n=157, 165 | -0.2 Points on scale | Standard Deviation 0.76 |
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 4 Mean OC, n=127, 116 | -0.4 Points on scale | Standard Deviation 0.65 |
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 8 Mean LOCF, n=157, 164 | -0.5 Points on scale | Standard Deviation 1.02 |
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 8 Mean OC, n=113, 106 | -0.7 Points on scale | Standard Deviation 0.87 |
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 12 Mean LOCF, n=157, 163 | -0.6 Points on scale | Standard Deviation 1.12 |
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 12 Mean OC, n=111, 98 | -0.9 Points on scale | Standard Deviation 0.9 |
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 1 Mean LOCF, n=157, 165 | -0.0 Points on scale | Standard Deviation 0.45 |
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 1 Mean OC, n=139, 143 | -0.1 Points on scale | Standard Deviation 0.4 |
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 2 Mean LOCF, n=157, 165 | -0.1 Points on scale | Standard Deviation 0.63 |
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 2 Mean OC, n=134, 132 | -0.2 Points on scale | Standard Deviation 0.59 |
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 3 Mean LOCF, n=157, 165 | -0.2 Points on scale | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 3 Mean OC, n=130, 127 | -0.3 Points on scale | Standard Deviation 0.61 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 3 Mean LOCF, n=157, 165 | -0.2 Points on scale | Standard Deviation 0.73 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 4 Mean LOCF, n=157, 165 | -0.2 Points on scale | Standard Deviation 0.83 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 1 Mean LOCF, n=157, 165 | 0.0 Points on scale | Standard Deviation 0.51 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 4 Mean OC, n=127, 116 | -0.4 Points on scale | Standard Deviation 0.77 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 2 Mean OC, n=134, 132 | -0.3 Points on scale | Standard Deviation 0.66 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 8 Mean LOCF, n=157, 164 | -0.5 Points on scale | Standard Deviation 1.01 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 1 Mean OC, n=139, 143 | -0.0 Points on scale | Standard Deviation 0.45 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 8 Mean OC, n=113, 106 | -0.9 Points on scale | Standard Deviation 0.85 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 3 Mean OC, n=130, 127 | -0.4 Points on scale | Standard Deviation 0.65 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 12 Mean LOCF, n=157, 163 | -0.6 Points on scale | Standard Deviation 1.15 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 2 Mean LOCF, n=157, 165 | -0.1 Points on scale | Standard Deviation 0.71 |
| Bupropion SR | Change From Baseline in Clinical Global Impressions - Severity of Illness (CGI-S) Scale at Weeks 1, 2, 3, 4, and 8 and 12 | Week 12 Mean OC, n=111, 98 | -1.1 Points on scale | Standard Deviation 0.98 |
Secondary
Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).
Time frame: Baseline to Week 8 and Week 12
Population: Full Analysis Set. Week 8 Last Observation Carried Forward (LOCF): placebo=152, Bupropion=160; Week 12 LOCF: placebo=155, Bupropion=160. Gastrointestinal, GI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Middle, Week 8 Mean LOCF | -0.4 points on a scale | Standard Deviation 0.87 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Depressed Mood, Week 12 Mean LOCF | -0.6 points on a scale | Standard Deviation 1.17 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Feelings of Guilt, Week 8 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.91 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Feelings of Guilt, Week 12 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.9 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Suicide, Week 8 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.82 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Suicide, Week 12 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.82 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Early, Week 8 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.83 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Early, Week 12 Mean LOCF | -0.4 points on a scale | Standard Deviation 0.85 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Depressed Mood, Week 8 Mean LOCF | -0.5 points on a scale | Standard Deviation 1.07 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Middle, Week 12 Mean LOCF | -0.4 points on a scale | Standard Deviation 0.91 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Late, Week 8 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.87 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Late, Week 12 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.91 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Work and Activities, Week 8 Mean LOCF | -0.4 points on a scale | Standard Deviation 0.93 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Work and Activities, Week 12 Mean LOCF | -0.6 points on a scale | Standard Deviation 1.13 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Retardation, Week 8 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.69 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Retardation, Week 12 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.78 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Agitation, Week 8 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.68 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Agitation, Week 12 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.77 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Psychic, Week 8 Mean LOCF | -0.3 points on a scale | Standard Deviation 1.16 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Psychic, Week 12 Mean LOCF | -0.5 points on a scale | Standard Deviation 1.26 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Somatic, Week 8 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.88 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Somatic, Week 12 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.89 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms GI, Week 8 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.61 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms GI, Week 12 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.64 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms General, Week 8 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.65 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms General, Week 12 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Genital Symptoms, Week 8 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.58 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Genital Symptoms, Week 12 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.66 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Hypochondriasis, Week 8 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.77 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Hypochondriasis, Week 12 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.78 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Loss of Weight by History, Week 8 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Loss of Weight by History, Week 12 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.63 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insight, Week 8 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.34 |
| Placebo | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insight, Week 12 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.38 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms General, Week 12 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.71 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Depressed Mood, Week 8 Mean LOCF | -0.5 points on a scale | Standard Deviation 1.2 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Agitation, Week 12 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.77 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Depressed Mood, Week 12 Mean LOCF | -0.6 points on a scale | Standard Deviation 1.3 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insight, Week 12 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.45 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Feelings of Guilt, Week 8 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.75 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Psychic, Week 8 Mean LOCF | -0.4 points on a scale | Standard Deviation 1.1 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Feelings of Guilt, Week 12 Mean LOCF | -0.4 points on a scale | Standard Deviation 0.77 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Genital Symptoms, Week 8 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.62 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Suicide, Week 8 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.73 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Psychic, Week 12 Mean LOCF | -0.5 points on a scale | Standard Deviation 1.19 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Suicide, Week 12 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.72 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Loss of Weight by History, Week 8 Mean LOCF | -0.0 points on a scale | Standard Deviation 0.58 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Early, Week 8 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.82 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Somatic, Week 8 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.92 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Early, Week 12 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.89 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Genital Symptoms, Week 12 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.71 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Middle, Week 8 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.73 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Somatic, Week 12 Mean LOCF | -0.4 points on a scale | Standard Deviation 0.99 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Middle, Week 12 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.79 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insight, Week 8 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.41 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Late, Week 8 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.78 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms GI, Week 8 Mean LOCF | 0.0 points on a scale | Standard Deviation 0.74 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Late, Week 12 Mean LOCF | -0.4 points on a scale | Standard Deviation 0.88 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Hypochondriasis, Week 8 Mean LOCF | -0.1 points on a scale | Standard Deviation 0.84 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Work and Activities, Week 8 Mean LOCF | -0.4 points on a scale | Standard Deviation 1.18 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms GI, Week 12 Mean LOCF | -0.0 points on a scale | Standard Deviation 0.8 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Work and Activities, Week 12 Mean LOCF | -0.5 points on a scale | Standard Deviation 1.35 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Loss of Weight by History, Week 12 Mean LOCF | 0.0 points on a scale | Standard Deviation 0.64 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Retardation, Week 8 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.68 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms General, Week 8 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.69 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Retardation, Week 12 Mean LOCF | -0.3 points on a scale | Standard Deviation 0.73 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Hypochondriasis, Week 12 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.89 |
| Bupropion SR | Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Agitation, Week 8 Mean LOCF | -0.2 points on a scale | Standard Deviation 0.77 |
Secondary
Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
Time frame: Baseline to Week 8 and Week 12
Population: Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12 | Week 8 Mean - Last Observation Carried Forward | -4.1 Score in a scale | Standard Deviation 7.07 |
| Placebo | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12 | Week 8 Mean - Observed Cases | -6.4 Score in a scale | Standard Deviation 5.77 |
| Placebo | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12 | Week 12 Mean - Observed Cases | -8.3 Score in a scale | Standard Deviation 6.38 |
| Bupropion SR | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12 | Week 8 Mean - Last Observation Carried Forward | -4.0 Score in a scale | Standard Deviation 7.6 |
| Bupropion SR | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12 | Week 8 Mean - Observed Cases | -7.4 Score in a scale | Standard Deviation 5.75 |
| Bupropion SR | Change From Baseline in the Hamilton Depression Scale (HAM-D 17 Items) Total Score at Week 8 and Total Score at Week 12 | Week 12 Mean - Observed Cases | -9.2 Score in a scale | Standard Deviation 5.98 |
Secondary
Hamilton Depression Scale (HAM-D 17 Items) Total Score
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
Time frame: Week 8 and Week 12
Population: Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Observed Cases: placebo = 111, Bupropion = 98
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Hamilton Depression Scale (HAM-D 17 Items) Total Score | Week 8 Mean - Last Observation Carried Forward | 15.8 Score in scale | Standard Deviation 8.04 |
| Placebo | Hamilton Depression Scale (HAM-D 17 Items) Total Score | Week 8 Mean - Observed Cases | 13.3 Score in scale | Standard Deviation 6.74 |
| Placebo | Hamilton Depression Scale (HAM-D 17 Items) Total Score | Week 12 Mean - Observed Cases | 11.3 Score in scale | Standard Deviation 7.09 |
| Bupropion SR | Hamilton Depression Scale (HAM-D 17 Items) Total Score | Week 8 Mean - Last Observation Carried Forward | 15.4 Score in scale | Standard Deviation 8.32 |
| Bupropion SR | Hamilton Depression Scale (HAM-D 17 Items) Total Score | Week 8 Mean - Observed Cases | 12.1 Score in scale | Standard Deviation 6.28 |
| Bupropion SR | Hamilton Depression Scale (HAM-D 17 Items) Total Score | Week 12 Mean - Observed Cases | 10.3 Score in scale | Standard Deviation 6.83 |
Secondary
Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2, with total HAM-D scores ranging from 0 (not ill) to 54 (severely ill).
Time frame: Baseline to Week 8 and Week 12
Population: Full Analysis Set. Last Observation Carried Forward, LOCF; Gastrointestinal, GI; Somatic, Som.; General, Gen.; Week, W.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Middle, Week 8 Mean LOCF, n=119, 124 | -42.0 percent change in score | Standard Deviation 53.28 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Depressed Mood, Week 12 Mean LOCF, n=155, 158 | -25.9 percent change in score | Standard Deviation 62.78 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Feelings of Guilt, Week 8 Mean LOCF, n=128, 131 | -24.9 percent change in score | Standard Deviation 55.1 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Feelings of Guilt, Week 12 Mean LOCF, n=129, 131 | -30.7 percent change in score | Standard Deviation 56.34 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Suicide, Week 8 Mean LOCF, n=79, 75 | -34.2 percent change in score | Standard Deviation 60.2 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Suicide, Week 12 Mean LOCF, n=80, 75 | -37.5 percent change in score | Standard Deviation 56.53 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Early, Week 8 Mean LOCF, n=112, 119 | -34.8 percent change in score | Standard Deviation 53.2 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Early, Week 12 Mean LOCF, n=114, 119 | -42.5 percent change in score | Standard Deviation 53.73 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Depressed Mood, Week 8 Mean LOCF, n=152, 158 | -17.7 percent change in score | Standard Deviation 60.38 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Middle, Week 12 Mean LOCF, n=122, 124 | -48.4 percent change in score | Standard Deviation 54.9 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Late, Week 8 Mean LOCF, n=109, 117 | -39.9 percent change in score | Standard Deviation 56.43 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Late, Week 12 Mean LOCF, n=110, 117 | -43.2 percent change in score | Standard Deviation 61.88 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Work and Activities, Week 8 Mean LOCF, n=151, 156 | -16.6 percent change in score | Standard Deviation 43.93 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Work and Activities, Week 12 Mean LOCF, n=154, 156 | -23.3 percent change in score | Standard Deviation 47.61 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Retardation, Week 8 Mean LOCF, n=114, 124 | -28.4 percent change in score | Standard Deviation 58.7 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Retardation, Week 12 Mean LOCF, n=117, 124 | -32.5 percent change in score | Standard Deviation 63.08 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Agitation, Week 8 Mean LOCF, n=87, 99 | -38.7 percent change in score | Standard Deviation 61.87 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Agitation, Week 12 Mean LOCF, n=89, 99 | -51.1 percent change in score | Standard Deviation 64.83 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Psychic, Week 8 Mean LOCF, n=146, 151 | -14.0 percent change in score | Standard Deviation 58.25 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Psychic, Week 12 Mean LOCF, n=148, 151 | -19.1 percent change in score | Standard Deviation 62.7 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Somatic, Week 8 Mean LOCF, n=144, 155 | -9.5 percent change in score | Standard Deviation 57.89 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Somatic, Week 12 Mean LOCF, n=147, 155 | -13.7 percent change in score | Standard Deviation 59.35 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms GI, Week 8 Mean LOCF, n=95, 93 | -30.5 percent change in score | Standard Deviation 56.16 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms GI, Week 12 Mean LOCF, n=97, 93 | -23.7 percent change in score | Standard Deviation 62.12 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms Gen., Week 8 Mean LOCF, n=146,152 | -13.4 percent change in score | Standard Deviation 50.61 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Som. Symptoms Gen., Week 12 Mean LOCF, n=149, 152 | -15.8 percent change in score | Standard Deviation 54.55 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Genital Symptoms, Week 8 Mean LOCF, n=115, 129 | -15.2 percent change in score | Standard Deviation 45.97 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Genital Symptoms, Week 12 Mean LOCF, n=118, 129 | -16.5 percent change in score | Standard Deviation 51.5 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Hypochondriasis, Week 8 Mean LOCF, n=93, 102 | -34.6 percent change in score | Standard Deviation 55.78 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Hypochondriasis, Week 12 Mean LOCF, n=95, 102 | -38.6 percent change in score | Standard Deviation 56.82 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Loss of Weight by Hist., W 8 Mean LOCF, n=32, 26 | -60.9 percent change in score | Standard Deviation 45.32 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Loss of Weight by Hist., W 12 Mean LOCF, n=34, 26 | -58.8 percent change in score | Standard Deviation 48.42 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insight, Week 8 Mean LOCF, n=48, 51 | -27.1 percent change in score | Standard Deviation 44.91 |
| Placebo | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insight, Week 12 Mean LOCF, n=49, 51 | -36.7 percent change in score | Standard Deviation 48.71 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Som. Symptoms Gen., Week 12 Mean LOCF, n=149, 152 | -23.7 percent change in score | Standard Deviation 51.13 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Depressed Mood, Week 8 Mean LOCF, n=152, 158 | -18.5 percent change in score | Standard Deviation 62.38 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Agitation, Week 12 Mean LOCF, n=89, 99 | -44.9 percent change in score | Standard Deviation 63.28 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Depressed Mood, Week 12 Mean LOCF, n=155, 158 | -22.2 percent change in score | Standard Deviation 68.41 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insight, Week 12 Mean LOCF, n=49, 51 | -47.1 percent change in score | Standard Deviation 50.41 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Feelings of Guilt, Week 8 Mean LOCF, n=128, 131 | -25.8 percent change in score | Standard Deviation 52.83 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Psychic, Week 8 Mean LOCF, n=146, 151 | -17.9 percent change in score | Standard Deviation 55.14 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Feelings of Guilt, Week 12 Mean LOCF, n=129, 131 | -30.8 percent change in score | Standard Deviation 53.61 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Genital Symptoms, Week 8 Mean LOCF, n=115, 129 | -21.7 percent change in score | Standard Deviation 45.86 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Suicide, Week 8 Mean LOCF, n=79, 75 | -26.7 percent change in score | Standard Deviation 70.87 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Psychic, Week 12 Mean LOCF, n=148, 151 | -21.0 percent change in score | Standard Deviation 66.45 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Suicide, Week 12 Mean LOCF, n=80, 75 | -26.0 percent change in score | Standard Deviation 74.14 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Loss of Weight by Hist., W 8 Mean LOCF, n=32, 26 | -51.9 percent change in score | Standard Deviation 57.41 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Early, Week 8 Mean LOCF, n=112, 119 | -29.8 percent change in score | Standard Deviation 54.59 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Somatic, Week 8 Mean LOCF, n=144, 155 | -13.9 percent change in score | Standard Deviation 60.12 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Early, Week 12 Mean LOCF, n=114, 119 | -31.9 percent change in score | Standard Deviation 58.49 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Genital Symptoms, Week 12 Mean LOCF, n=118, 129 | -29.5 percent change in score | Standard Deviation 50.24 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Middle, Week 8 Mean LOCF, n=119, 124 | -32.3 percent change in score | Standard Deviation 51.48 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Anxiety Somatic, Week 12 Mean LOCF, n=147, 155 | -17.7 percent change in score | Standard Deviation 63.07 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Middle, Week 12 Mean LOCF, n=122, 124 | -37.1 percent change in score | Standard Deviation 54.43 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insight, Week 8 Mean LOCF, n=48, 51 | -41.2 percent change in score | Standard Deviation 49.71 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Late, Week 8 Mean LOCF, n=109, 117 | -31.6 percent change in score | Standard Deviation 54.38 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms GI, Week 8 Mean LOCF, n=95, 93 | -25.8 percent change in score | Standard Deviation 63.68 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Insomnia Late, Week 12 Mean LOCF, n=110, 117 | -37.2 percent change in score | Standard Deviation 62.34 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Hypochondriasis, Week 8 Mean LOCF, n=93, 102 | -28.3 percent change in score | Standard Deviation 63.7 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Work and Activities, Week 8 Mean LOCF, n=151, 156 | -15.3 percent change in score | Standard Deviation 55.66 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms GI, Week 12 Mean LOCF, n=97, 93 | -34.9 percent change in score | Standard Deviation 65.02 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Work and Activities, Week 12 Mean LOCF, n=154, 156 | -19.4 percent change in score | Standard Deviation 62.51 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Loss of Weight by Hist., W 12 Mean LOCF, n=34, 26 | -57.7 percent change in score | Standard Deviation 57.78 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Retardation, Week 8 Mean LOCF, n=114, 124 | -31.0 percent change in score | Standard Deviation 53.19 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Somatic Symptoms Gen., Week 8 Mean LOCF, n=146,152 | -18.8 percent change in score | Standard Deviation 48.08 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Retardation, Week 12 Mean LOCF, n=117, 124 | -38.3 percent change in score | Standard Deviation 56.71 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Hypochondriasis, Week 12 Mean LOCF, n=95, 102 | -38.1 percent change in score | Standard Deviation 66.27 |
| Bupropion SR | Percentage of Change From Baseline in Each Item of the Hamilton Depression Scale (HAM-D 17 Items) Score at Weeks 8 and 12 | Agitation, Week 8 Mean LOCF, n=87, 99 | -44.9 percent change in score | Standard Deviation 60.4 |
Secondary
Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12.
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill).
Time frame: Baseline to Week 8 and Week 12
Population: Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12. | Week 8 Mean - Last Observation Carried Forward | -21.0 Percent Change in score | Standard Deviation 37.31 |
| Placebo | Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12. | Week 8 Mean - Observed Cases | -33.2 Percent Change in score | Standard Deviation 30.51 |
| Placebo | Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12. | Week 12 Mean - Last Observation Carried Forward | -26.5 Percent Change in score | Standard Deviation 41.65 |
| Placebo | Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12. | Week 12 Mean - Observed Cases | -43.0 Percent Change in score | Standard Deviation 32.51 |
| Bupropion SR | Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12. | Week 12 Mean - Observed Cases | -48.4 Percent Change in score | Standard Deviation 29.96 |
| Bupropion SR | Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12. | Week 8 Mean - Last Observation Carried Forward | -20.8 Percent Change in score | Standard Deviation 38.87 |
| Bupropion SR | Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12. | Week 12 Mean - Last Observation Carried Forward | -25.5 Percent Change in score | Standard Deviation 43.05 |
| Bupropion SR | Percentage of Change From Baseline of the Hamilton Depression (HAM-D 17 Items) Total Score at Weeks 8 and 12. | Week 8 Mean - Observed Cases | -38.2 Percent Change in score | Standard Deviation 28.68 |
Secondary
Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Remitters are defined as subjects with HAM-D total score ≤ 7.
Time frame: Baseline to Week 8 and Week 12
Population: Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160 Week 12 Observed Cases: placebo = 111, Bupropion = 98
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 8 Mean Last Observation Carried Forward | 18 Percentage of Remitters |
| Placebo | Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 8 Mean Observed Cases | 22 Percentage of Remitters |
| Placebo | Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 12 Mean Last Observation Carried Forward | 25 Percentage of Remitters |
| Placebo | Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 12 Mean Observed Cases | 33 Percentage of Remitters |
| Bupropion SR | Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 12 Mean Observed Cases | 38 Percentage of Remitters |
| Bupropion SR | Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 8 Mean Last Observation Carried Forward | 18 Percentage of Remitters |
| Bupropion SR | Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 12 Mean Last Observation Carried Forward | 24 Percentage of Remitters |
| Bupropion SR | Percentage of Remitters Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 8 Mean Observed Cases | 26 Percentage of Remitters |
Secondary
Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12
The Hamilton Rating Scale for Depression contains 17 questions which detect change and measure illness severity. Individual items are rated on a scale of 0-4, 0-3, and 0-2 with total HAM-D score range from 0 (not ill) to 52 (severely ill). Responders are defined as subjects with 50% or greater reduction from baseline in HAM-D total score.
Time frame: Baseline to Week 8 and Week 12
Population: Full Analysis Set. Week 8 Last Observation Carried Forward: placebo = 152, Bupropion = 160, Week 8 Observed Cases: placebo = 113, Bupropion = 106, Week 12 Last Observation Carried Forward: placebo = 155, Bupropion = 160, Week 12 Observed Cases: placebo = 111, Bupropion = 98
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 8 Mean Last Observation Carried Forward | 24 Percentage of Responders |
| Placebo | Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 8 Mean Observed Cases | 31 Percentage of Responders |
| Placebo | Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 12 Mean Last Observation Carried Forward | 37 Percentage of Responders |
| Placebo | Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 12 Mean Observed Cases | 50 Percentage of Responders |
| Bupropion SR | Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 12 Mean Observed Cases | 59 Percentage of Responders |
| Bupropion SR | Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 8 Mean Last Observation Carried Forward | 26 Percentage of Responders |
| Bupropion SR | Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 12 Mean Last Observation Carried Forward | 38 Percentage of Responders |
| Bupropion SR | Percentage of Responders Based on Hamilton Depression (HAM-D 17 Items) Scale Total Score at Weeks 8 and 12 | Week 8 Mean Observed Cases | 38 Percentage of Responders |
Secondary
Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12
The CGI-I assesses the investigator's impression of the patient's current illness. The time span is the week before the rating and the score ranges from 1 (very much improved) to 7 (very much worse). Responders are subjects that have a score of 1 (very much improved) or 2 (much improved) on the CGI-I.
Time frame: Baseline to Week 8 and Week 12
Population: Full Analysis set. Week 8 Last Observation Carried Forward: placebo = 153, Bupropion = 159; Week 8 Observed Cases: placebo = 113, Bupropion = 106; Week 12 Last Observation Carried Forward: placebo = 156, Bupropion = 158; Week 12 Observed Cases: placebo = 111, Bupropion = 98
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo | Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12 | Week 8 Mean Last Observation Carried Forward | 33 Percentage of Responders |
| Placebo | Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12 | Week 8 Mean Observed Cases | 42 Percentage of Responders |
| Placebo | Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12 | Week 12 Mean Last Observation Carried Forward | 44 Percentage of Responders |
| Placebo | Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12 | Week 12 Mean Observed Cases | 57 Percentage of Responders |
| Bupropion SR | Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12 | Week 12 Mean Observed Cases | 73 Percentage of Responders |
| Bupropion SR | Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12 | Week 8 Mean Last Observation Carried Forward | 38 Percentage of Responders |
| Bupropion SR | Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12 | Week 12 Mean Last Observation Carried Forward | 48 Percentage of Responders |
| Bupropion SR | Percentage of Responders Based on the Clinical Global Impression - Global Improvement (CGI-I) Scale at Weeks 8 and 12 | Week 8 Mean Observed Cases | 57 Percentage of Responders |
Secondary
Safety: Adverse Events by Organ System Class, Intensity, and Frequency
Assessment of intensity was based on investigators/subinvestigator's clinical judgement per protocol instructions: Mild event, easily tolerated, with minimal discomfort and not interfering with Activities of Daily Living (ADLs); moderate event, with discomfort that interferes with ADLs; severe event, prevents ADLs.
Time frame: Baseline to Week 12
Population: Safety population: comprised of participants who took at least one dose of the treatment period investigational product. The number of participants analyzed for this outcome measure represents the total number of events at each intensity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Parosmia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Libido decreased, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Nightmare, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | General Disorders (GD) - Any Event, mild | 10 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness, severe | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomach Discomfort, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Akathisia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Drug Withdrawal Syndrome, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomach Discomfort, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Drug Withdrawal Syndrome, moderate | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Thirst, mild | 4 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Akathisia, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Thirst, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Constipation, mild | 5 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Depressed Level of Consciousness, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Malaise, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Malaise, moderate | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Constipation, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Akathisia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Feeling abnormal, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema peripheral, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Somnolence, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema peripheral, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema peripheral, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Pain, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Skin & tissue disorders (SDO) - Any Event, mild | 6 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Anterograde Amnesia, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Urticaria, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Urticaria, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Depressed Level of Consciousness, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomatitis, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Rash, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Anterograde Amnesia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Toothache, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Eczema, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness, mild | 11 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Toothache, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperhidrosis, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperhidrosis, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Distension, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hypoesthesia facial, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Anterograde Amnesia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hypoesthesia facial, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pruritus generalised, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Tremor, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gastritis, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysarthria, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Hypoesthesia oral, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia areata, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Somnolence, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Dermatitis Contact, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Erythema, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Erythema, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Hypoesthesia oral, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysarthria, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperkeratosis, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Tremor, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysarthria, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pigmentation disorder, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Sweat Gland Disorder, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Headache, mild | 6 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Nasopharyngitis, mild | 31 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Investigations (INV) - Any Event, mild | 5 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Head discomfort, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Tremor, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Nasopharyngitis, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Head discomfort, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastrointestinal infection, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Weight decreased, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Any Event, severe | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis acute, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Head discomfort, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis acute, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Convulsion, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood Bilirubin increased, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood Bilirubin increased, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood Bilirubin increased, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis acute, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Glucose urine present, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hyperesthesia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Glucose urine present, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Glucose urine present, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Protein urine present, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hypoesthesia, mild | 5 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - White Blood Cell Count decreased, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - White Blood Cell Count decreased, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hyperesthesia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood pressure decreased, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood pressure decreased, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Enteritis Infectious, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Electrocardiogram T wave inversion, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Convulsion, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hematocrit decreased, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Enteritis Infectious, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hematocrit decreased, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hyperesthesia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Enteritis Infectious, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Red Blood Cell Count decreased, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Headache, moderate | 3 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis viral, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Musculoskeletal Disorders (MD) - Any Event, mild | 9 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Loss of consciousness, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis viral, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Convulsion, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Back Pain, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Musculoskeletal stiffness, mild | 3 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis viral, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Otitis Externa, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Loss of consciousness, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Purulence, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hypoesthesia, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Loss of consciousness, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Neck Pain, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Purulence, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain Lower, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness postural, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Rhinitis, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Pain in extremity, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Paraesthesia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Arthralgia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Arthralgia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Arthralgia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Rhinitis, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Pharyngolaryngeal Pain, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hypoesthesia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Respiratory Disorders (RTM) - Any Event, mild | 4 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM -Any Event, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Any Event, severe | 7 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM-Upp. respiratory Tract inflammation, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Paraesthesia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Cough, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness postural, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Cough, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Insomnia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Cough, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Paraesthesia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Insomnia, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Joint sprain, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness, moderate | 4 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Joint sprain, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Insomnia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Rib fracture, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Gastrointestinal Disorders (GID)-Any Event, mild | 28 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Rib fracture, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mood altered, mild | 3 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Rib fracture, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness postural, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Thermal Burn, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mood altered, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Thermal Burn, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Any Event, moderate | 15 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Thermal Burn, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mood altered, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Wound, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysgeusia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Wound, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mania, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Wound, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Any Event, severe | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Ear Disorders (ED) - Any Event, mild | 3 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mania, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Any Event, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysesthesia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mania, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Tinnitus, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Nausea, mild | 12 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Anxiety, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Chalazion, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Headache, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Chalazion, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Anxiety, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Abnormal sensations in eye, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Nervous System Disorders (NSD) - Any Event, mild | 32 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Abnormal sensations in eye, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysesthesia, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Abnormal sensations in eye, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Anxiety, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Conjunctival haemorrhage, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Nausea, severe | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Anorexia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bipolar Disorder, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Dehydration, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysgeusia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Dehydration, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Delerium, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Dehydration, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Diarrhea, mild | 6 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hyperlipidemia, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Delerium, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hyperlipidemia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysesthesia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hyperlipidemia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Delerium, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hypovitaminosis, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Diarrhea, moderate | 3 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hypovitaminosis, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression suicidal, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hypovitaminosis, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Dysphoria, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Vascular Disorders (VD) - Any Event, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Any Event, moderate | 8 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Anemia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Dysphoria, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Anemia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Diarrhea, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Lymphadenopathy, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Parosmia, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Lymphadenopathy, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Early morning awakening, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Lymphadenopathy, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Vomiting, mild | 4 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Hepatobiliary disorders (HD) - Any Event, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Early morning awakening, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | HD - Any Event, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysgeusia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | HD - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Menometrorrhagia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Early morning awakening, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Menometrorrhagia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Vomiting, moderate | 4 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Menometrorrhagia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hallucination, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Somnolence, mild | 10 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Premenstrual Syndrome, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hallucination, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Premenstrual Syndrome, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Vomiting, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Cardiac Disorders (CD) - Any Event, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hallucination, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | CD - Any Event, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Parosmia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | CD - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain upper, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | CD - Palpitations, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Depressed Level of Consciousness, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | CD - Palpitations, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain upper, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Renal & Urinary Disorders (RUD) - Any Event, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Joint sprain, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gingival Swelling, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Infections and Infestations (INF)-Any Event, mild | 38 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Any Event, moderate | 3 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Nasopharyngitis, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastrointestinal infection, mild | 3 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastrointestinal infection, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Otitis Externa, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Otitis Externa, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Rhinitis, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Vaginal Candidiasis, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Vaginal Candidiasis, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Vaginal Candidiasis, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Psychiatric Disorders (PsyDO) - Any Event, mild | 8 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Any Event, moderate | 13 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression, moderate | 11 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression, severe | 7 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bipolar Disorder, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bipolar Disorder, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bruxism, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bruxism, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bruxism, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression suicidal, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression suicidal, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hypomania, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hypomania, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hypomania, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Intentional self-injury, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Intentional self-injury, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Intentional self-injury, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Libido decreased, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Libido decreased, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Nightmare, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Nightmare, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Any Event, moderate | 5 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Drug Withdrawal Syndrome, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Thirst, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Malaise, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Feeling abnormal, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Feeling abnormal, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Irritability, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Irritability, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Irritability, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Chills, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Chills, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Chills, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Pain, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Pain, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Any Event, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Urticaria, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Rash, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Rash, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Eczema, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Eczema, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperhidrosis, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hypoesthesia facial, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pruritus generalised, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pruritus generalised, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia areata, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia areata, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Dermatitis Contact, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Dermatitis Contact, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Erythema, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hemorrhage subcutaneous, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hemorrhage subcutaneous, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hemorrhage subcutaneous, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperkeratosis, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperkeratosis, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pigmentation disorder, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pigmentation disorder, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Sweat Gland Disorder, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Sweat Gland Disorder, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Any Event, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Alanine Aminotransferase increased, mild | 3 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Alanine Aminotransferase increased, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Alanine Aminotransferase increased, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Weight decreased, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Weight decreased, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Aspartate Aminotransferase increased, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV-Aspartate Aminotransferase increased, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Aspartate Aminotransferase increased, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Protein urine present, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Protein urine present, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - White Blood Cell Count decreased, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood pressure decreased, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Electrocardiogram T wave inversion, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Electrocardiogram T wave inversion, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hematocrit decreased, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hemoglobin decreased, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hemoglobin decreased, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hemoglobin decreased, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Red Blood Cell Count decreased, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Red Blood Cell Count decreased, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Any Event, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Back Pain, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Back Pain, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Musculoskeletal stiffness, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Musculoskeletal stiffness, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Myalgia, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Myalgia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Myalgia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Neck Pain, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Neck Pain, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Nausea, moderate | 8 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Constipation, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Purulence, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Dysphoria, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Head Injury, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Premenstrual Syndrome, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | CD - Palpitations, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Pain in extremity, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Pain in extremity, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Pharyngolaryngeal Pain, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Fasciitis, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Fasciitis, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Fasciitis, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM -Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Upper respiratory Tract inflammation, mild | 3 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM-Upp. respiratory Tract inflammation, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Asthma, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Asthma, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Asthma, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Pharyngolaryngeal Pain, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Injury and complications (IPPC) - Any Event, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Any Event, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Contusion, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Contusion, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Contusion, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Intentional Overdose, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Intentional Overdose, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Intentional Overdose, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Head Injury, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Head Injury, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain upper, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Tinnitus, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Tinnitus, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Ear Discomfort, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Ear Discomfort, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Ear Discomfort, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Eye Disorders (EyeDO) - Any Event, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Any Event, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Chalazion, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Conjunctival haemorrhage, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Conjunctival haemorrhage, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Metabolism Disorders (MetDO) - Any Event, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Any Event, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Anorexia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Anorexia, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Any Event, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hot Flush, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hot Flush, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hot Flush, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hypertension, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hypertension, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hypertension, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Blood & Lymph Disorders (BLD) - Any Event, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Any Event, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Anemia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | HD - Hepatic Function abnormal, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | HD - Hepatic Function abnormal, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | HD - Hepatic Function abnormal, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Reproductive Disorders (RBD) - Any Event, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Any Event, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Galactorrhea, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Galactorrhea, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Galactorrhea, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Any Event, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Dysuria, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Dysuria, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Dysuria, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Pollakiuria, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Pollakiuria, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Pollakiuria, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Endocrine Disorders (ENDO) - Any Event, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ENDO - Any Event, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ENDO - Any Event, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ENDO - Hyperprolactinaemia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ENDO - Hyperprolactinaemia, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ENDO - Hyperprolactinaemia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomach Discomfort, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomatitis, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomatitis, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Toothache, mild | 2 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Distension, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Distension, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gastritis, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gastritis, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Hypoesthesia oral, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Melaena, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Melaena, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Melaena, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain Lower, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain Lower, moderate | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Dyspepsia, mild | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Dyspepsia, moderate | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Dyspepsia, severe | 0 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gingival Swelling, mild | 1 Number of events |
| Placebo | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gingival Swelling, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain upper, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Intentional Overdose, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomatitis, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Renal & Urinary Disorders (RUD) - Any Event, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomatitis, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Intentional Overdose, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomatitis, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Weight decreased, mild | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Toothache, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hypertension, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Distension, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Intentional Overdose, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Head Injury, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gastritis, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Pollakiuria, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gastritis, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood Bilirubin increased, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Hypoesthesia oral, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood Bilirubin increased, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Melaena, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Glucose urine present, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Melaena, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Head Injury, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Melaena, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Protein urine present, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain Lower, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Blood & Lymph Disorders (BLD) - Any Event, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain Lower, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain Lower, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - White Blood Cell Count decreased, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Dyspepsia, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Head Injury, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Dyspepsia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - White Blood Cell Count decreased, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Dyspepsia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood pressure decreased, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gingival Swelling, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Any Event, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood pressure decreased, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gingival Swelling, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Any Event, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Infections and Infestations (INF)-Any Event, mild | 30 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Electrocardiogram T wave inversion, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Tinnitus, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Nasopharyngitis, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ENDO - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastrointestinal infection, mild | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hematocrit decreased, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hematocrit decreased, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Tinnitus, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis viral, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hemoglobin decreased, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Otitis Externa, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Ear Discomfort, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Otitis Externa, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Rhinitis, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hemoglobin decreased, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Rhinitis, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Vaginal Candidiasis, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Ear Discomfort, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Vaginal Candidiasis, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | HD - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Vaginal Candidiasis, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Ear Discomfort, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Psychiatric Disorders (PsyDO) - Any Event, mild | 10 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Back Pain, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Pollakiuria, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression, moderate | 9 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Back Pain, moderate | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Eye Disorders (EyeDO) - Any Event, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bipolar Disorder, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Back Pain, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bipolar Disorder, severe | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | HD - Hepatic Function abnormal, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bruxism, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Any Event, moderate | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bruxism, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Dysuria, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bruxism, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression suicidal, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression suicidal, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | HD - Hepatic Function abnormal, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression suicidal, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hallucination, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ENDO - Hyperprolactinaemia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hypomania, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Neck Pain, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hypomania, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Conjunctival haemorrhage, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Neck Pain, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | HD - Hepatic Function abnormal, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Constipation, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Conjunctival haemorrhage, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Libido decreased, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Dysuria, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Libido decreased, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Metabolism Disorders (MetDO) - Any Event, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Nightmare, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Nightmare, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Nightmare, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pruritus generalised, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Drug Withdrawal Syndrome, moderate | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM-Upp. respiratory Tract inflammation, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Drug Withdrawal Syndrome, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Injury and complications (IPPC) - Any Event, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Malaise, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Reproductive Disorders (RBD) - Any Event, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Malaise, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Any Event, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Feeling abnormal, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Endocrine Disorders (ENDO) - Any Event, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Feeling abnormal, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | CD - Palpitations, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Irritability, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ENDO - Any Event, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Irritability, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Irritability, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Pain in extremity, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Chills, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Any Event, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Chills, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Arthralgia, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Chills, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Arthralgia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Anorexia, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema peripheral, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Dysuria, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Pain, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Pharyngolaryngeal Pain, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Pain, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Pain, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Skin & tissue disorders (SDO) - Any Event, mild | 8 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Fasciitis, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Anorexia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Any Event, severe | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Fasciitis, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Urticaria, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Vascular Disorders (VD) - Any Event, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Respiratory Disorders (RTM) - Any Event, mild | 6 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Any Event, severe | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Eczema, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM -Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Eczema, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Any Event, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperhidrosis, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hypoesthesia facial, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Upper respiratory Tract inflammation, mild | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hypoesthesia facial, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ENDO - Hyperprolactinaemia, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pruritus generalised, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM-Upp. respiratory Tract inflammation, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pruritus generalised, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Asthma, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia areata, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Galactorrhea, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Asthma, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Dermatitis Contact, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Dermatitis Contact, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hot Flush, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Dermatitis Contact, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Erythema, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RUD - Pollakiuria, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Erythema, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Pharyngolaryngeal Pain, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hemorrhage subcutaneous, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hot Flush, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Galactorrhea, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hemorrhage subcutaneous, severe | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperkeratosis, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Any Event, moderate | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hot Flush, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperkeratosis, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ENDO - Hyperprolactinaemia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pigmentation disorder, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hypertension, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Sweat Gland Disorder, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Contusion, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Investigations (INV) - Any Event, mild | 10 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Galactorrhea, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Contusion, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | VD - Hypertension, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hypovitaminosis, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Anemia, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Anemia, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Anemia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Lymphadenopathy, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Lymphadenopathy, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | BLD - Lymphadenopathy, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Hepatobiliary disorders (HD) - Any Event, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | HD - Any Event, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Menometrorrhagia, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Menometrorrhagia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Menometrorrhagia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Premenstrual Syndrome, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Premenstrual Syndrome, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RBD - Premenstrual Syndrome, severe | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Cardiac Disorders (CD) - Any Event, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | CD - Any Event, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | CD - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | CD - Palpitations, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | CD - Palpitations, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Abnormal sensations in eye, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Nervous System Disorders (NSD) - Any Event, mild | 31 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Any Event, moderate | 16 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Any Event, severe | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness, mild | 8 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness, moderate | 8 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Headache, mild | 8 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Headache, moderate | 6 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Headache, severe | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Somnolence, mild | 8 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Somnolence, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hypoesthesia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Somnolence, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hypoesthesia, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hypoesthesia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysgeusia, mild | 4 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysgeusia, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysgeusia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Depressed Level of Consciousness, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Depressed Level of Consciousness, moderate | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Depressed Level of Consciousness, severe | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Tremor, mild | 4 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Tremor, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Tremor, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Convulsion, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Convulsion, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Convulsion, severe | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness postural, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness postural, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dizziness postural, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysesthesia, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysesthesia, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysesthesia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Akathisia, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Parosmia, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Parosmia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Parosmia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Akathisia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Akathisia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Anterograde Amnesia, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Anterograde Amnesia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Anterograde Amnesia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysarthria, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysarthria, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Dysarthria, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Head discomfort, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Head discomfort, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Head discomfort, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hyperesthesia, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hyperesthesia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Hyperesthesia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Loss of consciousness, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Loss of consciousness, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Loss of consciousness, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Paraesthesia, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Paraesthesia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | NSD - Paraesthesia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Gastrointestinal Disorders (GID)-Any Event, mild | 32 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Any Event, moderate | 14 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Nausea, mild | 16 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Nausea, moderate | 10 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Nausea, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Diarrhea, mild | 6 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Diarrhea, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Diarrhea, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Vomiting, mild | 5 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Vomiting, moderate | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Vomiting, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain upper, mild | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain upper, moderate | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomach Discomfort, mild | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomach Discomfort, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Stomach Discomfort, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Constipation, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Constipation, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain, mild | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Pain, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Toothache, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Toothache, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Distension, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Abdominal Distension, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gastritis, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Hypoesthesia oral, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Hypoesthesia oral, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GID - Gingival Swelling, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Any Event, moderate | 4 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Nasopharyngitis, mild | 24 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Nasopharyngitis, moderate | 4 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastrointestinal infection, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastrointestinal infection, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis acute, mild | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis acute, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis acute, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Bronchitis, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Enteritis Infectious, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Enteritis Infectious, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Enteritis Infectious, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis viral, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Gastroenteritis viral, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Otitis Externa, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Purulence, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Purulence, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Purulence, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INF - Rhinitis, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Any Event, moderate | 14 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Any Event, severe | 5 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Depression, severe | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Insomnia, mild | 4 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Insomnia, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Insomnia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mood altered, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mood altered, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mood altered, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mania, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mania, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Mania, severe | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Anxiety, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Anxiety, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Anxiety, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Bipolar Disorder, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Delerium, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Delerium, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Delerium, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Dysphoria, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Dysphoria, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Dysphoria, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Early morning awakening, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Early morning awakening, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Early morning awakening, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hallucination, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hallucination, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Hypomania, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Intentional self-injury, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Intentional self-injury, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Intentional self-injury, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | PsyDO - Libido decreased, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | General Disorders (GD) - Any Event, mild | 16 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Any Event, moderate | 5 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Drug Withdrawal Syndrome, mild | 6 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Thirst, mild | 9 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Thirst, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Thirst, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Malaise, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Feeling abnormal, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema peripheral, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | GD - Edema peripheral, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Any Event, moderate | 6 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Urticaria, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Urticaria, moderate | 4 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Rash, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Rash, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Rash, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Eczema, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperhidrosis, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperhidrosis, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hypoesthesia facial, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia areata, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Alopecia areata, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Erythema, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hemorrhage subcutaneous, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Hyperkeratosis, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pigmentation disorder, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Pigmentation disorder, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Sweat Gland Disorder, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | SDO - Sweat Gland Disorder, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Any Event, moderate | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Alanine Aminotransferase increased, mild | 4 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Alanine Aminotransferase increased, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Alanine Aminotransferase increased, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Weight decreased, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Weight decreased, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Aspartate Aminotransferase increased, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV-Aspartate Aminotransferase increased, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Aspartate Aminotransferase increased, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood Bilirubin increased, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Glucose urine present, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Glucose urine present, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Protein urine present, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Protein urine present, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - White Blood Cell Count decreased, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Blood pressure decreased, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Electrocardiogram T wave inversion, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Electrocardiogram T wave inversion, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hematocrit decreased, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Hemoglobin decreased, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Red Blood Cell Count decreased, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Red Blood Cell Count decreased, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | INV - Red Blood Cell Count decreased, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Musculoskeletal Disorders (MD) - Any Event, mild | 6 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Any Event, moderate | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Musculoskeletal stiffness, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Musculoskeletal stiffness, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Musculoskeletal stiffness, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Myalgia, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Myalgia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Myalgia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Neck Pain, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Contusion, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Pain in extremity, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Pain in extremity, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Arthralgia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MD - Fasciitis, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM -Any Event, moderate | 3 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Pharyngolaryngeal Pain, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Asthma, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Cough, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Cough, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | RTM - Cough, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Joint sprain, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Joint sprain, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Joint sprain, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Rib fracture, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Rib fracture, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Rib fracture, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Thermal Burn, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Thermal Burn, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Thermal Burn, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Wound, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Wound, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | IPPC - Wound, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | Ear Disorders (ED) - Any Event, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Any Event, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Any Event, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | ED - Tinnitus, mild | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Chalazion, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Chalazion, moderate | 2 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Chalazion, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Abnormal sensations in eye, moderate | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Abnormal sensations in eye, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | EyeDO - Conjunctival haemorrhage, mild | 1 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Anorexia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Dehydration, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Dehydration, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Dehydration, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hyperlipidemia, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hyperlipidemia, moderate | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hyperlipidemia, severe | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hypovitaminosis, mild | 0 Number of events |
| Bupropion SR | Safety: Adverse Events by Organ System Class, Intensity, and Frequency | MetDO - Hypovitaminosis, moderate | 0 Number of events |
Secondary
Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12
Kaplan-Meier estimates were calculated using event or censoring and time to event or censoring. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).
Time frame: Week 12
Population: Full analysis set. Participants at risk refers to participants with either a censoring or event time beyond the time point of interest (Week 12).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12 | Participants at risk | 102 participants |
| Placebo | Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12 | Participants not at risk | 55 participants |
| Bupropion SR | Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12 | Participants at risk | 90 participants |
| Bupropion SR | Study Continuation Rate as Assessed by the Number of Participants at Risk at Week 12 | Participants not at risk | 75 participants |
p-value: 0.036Log Rank